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Clinical Practice Guideline for the Treatment of Intrinsic Circadian

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Clinical Practice Guideline for the Treatment of Intrinsic Circadian SPECIAL ARTICLES pii: jc-00358-15 http://dx.doi.org/10.5664/jcsm.5100 Clinical Practice Guideline for the Treatment of Intrinsic Circadian Rhythm Sleep-Wake Disorders: Advanced Sleep- Wake Phase Disorder (ASWPD), Delayed Sleep-Wake Phase Disorder (DSWPD), Non-24-Hour Sleep-Wake Rhythm Disorder (N24SWD), and Irregular Sleep-Wake Rhythm Disorder (ISWRD). An Update for 2015 An American Academy of Sleep Medicine Clinical Practice Guideline R. Robert Auger, MD1; Helen J. Burgess, PhD2; Jonathan S. Emens, MD3; Ludmila V. Deriy, PhD4; Sherene M. Thomas, PhD4; Katherine M. Sharkey, MD, PhD5 1Mayo Center for Sleep Medicine, Rochester, MN; 2Rush University Medical Center, Chicago, IL; 3Portland VA Medical Center, Portland, OR; 4American Academy of Sleep Medicine, Darien, IL; 5Brown University, Providence, RI A systematic literature review and meta-analyses (where second- and fi rst-tier degree of confi dence, respectively. No appropriate) were performed and the GRADE approach was recommendations were provided for remaining treatments/ used to update the previous American Academy of Sleep populations, due to either insuffi cient or absent data. Areas Medicine Practice Parameters on the treatment of intrinsic where further research is needed are discussed. circadian rhythm sleep-wake disorders. Available data Keywords: circadian rhythms, DSWPD, ASWPD, N24SWD, allowed for positive endorsement (at a second-tier degree of ISWRD confi dence) of strategically timed melatonin (for the treatment Citation: Auger RR, Burgess HJ, Emens JS, Deriy LV, of DSWPD, blind adults with N24SWD, and children/ Thomas SM, Sharkey KM. Clinical practice guideline for the adolescents with ISWRD and comorbid neurological disorders), treatment of intrinsic circadian rhythm sleep-wake disorders: and light therapy with or without accompanying behavioral advanced sleep-wake phase disorder (ASWPD), delayed interventions (adults with ASWPD, children/adolescents with sleep-wake phase disorder (DSWPD), non-24-hour sleep- DSWPD, and elderly with dementia). Recommendations wake rhythm disorder (N24SWD), and irregular sleep-wake against the use of melatonin and discrete sleep-promoting rhythm disorder (ISWRD). An update for 2015. J Clin Sleep medications are provided for demented elderly patients, at a Med 2015;11(10):1199 –1236 . SUMMARY the TF. The TF developed consensus-based relevant outcomes, rated their relative importance, and determined clinical signifi - cance thresholds. Extracted data were pooled across studies Purpose for each outcome measure in accordance with PICO questions, The present document replaces/updates the previous Ameri- and based upon CRSWD diagnosis, study design, patient pop- can Academy of Sleep Medicine (AASM) Practice Parameters ulation, outcome of interest, and method of derivation. Statis- pertaining to the intrinsic CRSWDs (i.e., ASWPD, DSWPD, tical analyses were performed using dedicated software, and N24SWD, and ISWRD). The treatment of remaining CRSWDs meta-analyses were completed when applicable. The GRADE is not addressed. (Grading of Recommendations Assessment, Development, and Evaluation) approach was used to develop recommenda- Methodology tion statements and to determine the direction and strengths of The AASM commissioned a Task Force (TF) of 4 members these recommendations based upon a composite assessment of with expertise in the fi eld of CRSWDs, appointed a Board of evidence quality, benefi ts versus harms analyses, and patient Directors (BOD) liaison, and assigned a Science and Research values and preferences. Department staff member to manage the project. PICO (Pa- tient, Population or Problem, Intervention, Comparison, and Findings Outcomes) questions were developed by the TF and approved Available data allowed for positive endorsement (at a sec- by the BOD. Extensive literature searches were performed to ond-tier degree of confi dence) of strategically timed melatonin identify articles of interest, and relevant data were extracted by (for the treatment of DSWPD, blind adults with N24SWD, and 1199 Journal of Clinical Sleep Medicine, Vol. 11, No. 10, 2015 RR Auger, HJ Burgess, JS Emens et al. children/adolescents with ISWRD and comorbid neurologi- 5.4.6.2a The TF suggests that clinicians use strategically cal disorders), and light therapy with or without accompany- timed melatonin as a treatment for ISWRD in children/ ing behavioral interventions (adults with ASWPD, children/ adolescents with neurologic disorders (versus no treatment). adolescents with DSWPD, and elderly with dementia and [WEAK FOR] ISWRD). Recommendations against the use of melatonin and discrete sleep-promoting medications are provided for de- 5.4.9.1a The TF suggests that clinicians avoid the use mented elderly patients, at a second- and first-tier degree of of combined treatments consisting of light therapy in confidence, respectively. No recommendations were provided combination with melatonin in demented, elderly patients for remaining treatments/populations, due to either insufficient with ISWRD (versus no treatment). [WEAK AGAINST] or absent data. Conclusion Recommendations are as Follows Use of the GRADE system for this updated Clinical Prac- tice Guideline represents a major change. This update should ASWPD provide clinicians with heightened confidence with respect to 5.1.4a The TF suggests that clinicians treat adult ASWPD prescribing select treatments and, equally importantly, should patients with evening light therapy (versus no treatment). serve as a roadmap for future studies that will propel higher [WEAK FOR] quality, more sophisticated therapies for the intrinsic CRSWDs. DSWPD 5.2.6.1a The TF suggests that clinicians treat DSWPD in adults with and without depression with strategically timed melatonin (versus no treatment). [WEAK FOR] 5.2.6.2.1a The TF suggests that clinicians treat children and adolescents with DSWPD (and no comorbidities) with strategically timed melatonin (versus no treatment). [WEAK FOR] 5.2.6.2.2a The TF suggests that clinicians treat children and adolescents with DSWPD comorbid with psychiatric conditions with strategically timed melatonin (versus no treatment). [WEAK FOR] 5.2.9.2a The TF suggests that clinicians treat children and adolescents with DSWPD with post-awakening light therapy in conjunction with behavioral treatments (versus no treatment). [WEAK FOR] N24SWD 5.3.6.1a The TF suggests that clinicians use strategically timed melatonin for the treatment of N24SWD in blind adults (versus no treatment). [WEAK FOR] ISWRD 5.4.4a The TF suggests that clinicians treat ISWRD in elderly patients with dementia with light therapy (versus no treatment). [WEAK FOR] 5.4.5a The TF recommends that clinicians avoid the use of sleep-promoting medications to treat demented elderly patients with ISWRD (versus no treatment). [STRONG AGAINST] 5.4.6.1a The TF suggests that clinicians avoid the use of melatonin as a treatment for ISWRD in older people with dementia (versus no treatment). [WEAK AGAINST] Journal of Clinical Sleep Medicine, Vol. 11, No. 10, 2015 1200 Treatment of Intrinsic Circadian Rhythm Sleep-Wake Disorders 1.0 INTRODUCTION for the governance of sleep and wakefulness: “Process S” and “Process C.”6 The homeostatic drive to sleep (Process S) is pro- The American Academy of Sleep Medicine (AASM) pro- portional to the duration of wakefulness. In contrast, Process C duced the first Practice Parameters (and associated reviews) for creates a drive for wakefulness that variably opposes Process S the evaluation and treatment of circadian rhythm sleep-wake and is dependent upon circadian (“approximately daily”) rhythms disorders (CRSWDs) in 2007.1–3 The purpose of the present intrinsic to the individual. Master coordination of this sleep/wake publication is to provide an evidence-based update of existing rhythm is provided by the neurons of the suprachiasmatic nuclei recommendations for the treatment of the intrinsic CRSWDs: located within the hypothalamus.7–10 As this intrinsic period is advanced sleep-wake phase disorder (ASWPD), delayed sleep- typically slightly longer than 24 hours in humans11,12 synchroni- wake phase disorder (DSWPD), non-24-hour sleep-wake zation to the 24-hour day (entrainment) is accomplished by vari- rhythm disorder (N24SWD), and irregular sleep-wake rhythm ous environmental inputs, the most important of which is light disorder (ISWRD). The extrinsic or predominantly environ- and dark exposure.13 Failure to synchronize can alter the phase mentally influenced CRSWDs, namely shift work and jet lag relationships between internal rhythms and the light/dark cycle, disorder, are not addressed in this paper. which may manifest in the form of circadian rhythm sleep-wake disorders (CRSWDs). The intrinsic CRSWDs refer to those con- 2.0 BACKGROUND ditions that are thought to exist predominantly due to innate phe- nomena, although exogenous components contribute to varying Reviewed studies that included patients with an explicitly degrees in all of these disorders. stated CRSWD predominantly utilized the International Classi- The intrinsic CRSWDs are briefly characterized as follows. fication of Sleep Disorders, Second Edition (ICSD-2)4 diagnostic DSWPD manifests as a delay of the major sleep episode with criteria, despite the fact that International Classification of Sleep respect to the patient’s desired timing or the timing required to Disorders, Third Edition (ICSD-3)5 nomenclature is referenced attend to social, educational, and/or occupational demands. Pa- throughout the manuscript. Important modifications
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